MAUDE Adverse Event Report: COOK ENDOSCOPY HERCULES 3 STAGE BALLOON ESOPHAGEAL; KNQ, DILATOR, ESOPHAGEAL

Catalog Number	HBD-15-16.5-18
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: (b)(6) 2018.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.It is unknown if the user applied negative pressure and lubrication to the balloon prior to advancement through the endoscope accessory channel.A possible contributing factor to a leakage is failure to apply negative pressure and lubrication to the balloon prior to advancement.The instructions for use advise the user: "to facilitate passage through the endoscope, apply negative pressure to the catheter." the application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.Negative pressure will also aid in balloon preservation and optimize balloon performance.The instructions for use also advise the user: "maintain balloon deflation with negative pressure and introduce into the accessory channel of the endoscope, advancing in short increments until the dilator is completely visualized endoscopically." the instructions for use advise the user: "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." this activity will aid in balloon preservation.A possible contributing factor to a leakage in the balloon material is using a compromised inflation device to inflate the balloon.If the pressure reading of the inflation device is inaccurate, this could contribute to over inflation, possibly resulting in damage to the balloon material.A leakage can occur if the balloon comes into contact with a sharp object or a burr in the endoscope channel.Prior to distribution, all hercules 3 stage balloons esophageal are subjected to a leak test to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During a dilation procedure, the physician used a cook hercules 3 stage balloon esophageal.Per medwatch form (b)(4): "while using a dilation balloon, the equipment failed to stay dilated during the procedure.The [physician] wanted to make sure the company was aware of the faulty product." although a portion of specific patient outcome information has not yet been provided, the initial reporter specified that the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Continued from section d3 - date of event: (b)(6) 2018.Continued from section e3 - occupation: non healthcare professional.Investigation evaluation: a product evaluation was not performed in response to this report because the product said to be involved was not provided to cook for evaluation.The report could not be confirmed.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: we could not conduct a complete investigation because the product said to be involved was not returned for evaluation.A definitive cause for the reported observation could not be determined.It is unknown if the user applied negative pressure and lubrication to the balloon prior to advancement through the endoscope accessory channel.A possible contributing factor to a leakage is failure to apply negative pressure and lubrication to the balloon prior to advancement.The instructions for use advise the user: "to facilitate passage through the endoscope, apply negative pressure to the catheter." the application of negative pressure will aspirate all residual air from the balloon and ease endoscopic advancement.Negative pressure will also aid in balloon preservation and optimize balloon performance.The instructions for use also advise the user: "maintain balloon deflation with negative pressure and introduce into the accessory channel of the endoscope, advancing in short increments until the dilator is completely visualized endoscopically." the instructions for use advise the user: "apply a lubricating agent to the balloon to facilitate passage through the endoscope accessory channel." this activity will aid in balloon preservation.A possible contributing factor to a leakage in the balloon material is using a compromised inflation device to inflate the balloon.If the pressure reading of the inflation device is inaccurate, this could contribute to over inflation, possibly resulting in damage to the balloon material.A leakage can occur if the balloon comes into contact with a sharp object or a burr in the endoscope channel.Prior to distribution, all hercules 3 stage balloons esophageal are subjected to a leak test to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted.The likelihood of occurrence is considered rare.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.
Event or Problem Description
During a dilation procedure, the physician used a cook hercules 3 stage balloon esophageal.Per medwatch form 2600320000-2018-8089: "while using a dilation balloon, the equipment failed to stay dilated during the procedure.The [physician] wanted to make sure the company was aware of the faulty product." additional information was received on 21-sep-2018 that the balloon had ruptured.Although a portion of specific patient outcome information was not provided, the initial reporter specified that the patient did not experience any adverse effects due to this occurrence.

• Brand Name: HERCULES 3 STAGE BALLOON ESOPHAGEAL
• Common Device Name: KNQ, DILATOR, ESOPHAGEAL
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• MDR Report Key: 7901787
• Report Number: 1037905-2018-00432
• Device Sequence Number: 11150928
• Product Code: KNQ
• UDI-Device Identifier: 00827002487321
• UDI-Public: (01)00827002487321(17)210507(10)W4063645
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2021
• Device Catalogue Number: HBD-15-16.5-18
• Device Lot Number: W4063645
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2018
• Supplement Date Received by Manufacturer: 09/20/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR